Comparing the Outcomes of Intracytoplasmic Sperm Injection (ICSI) Using the Zona Pellucida-Bound Sperm Versus Conventional Manually Selected Sperm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Blastulation Rate
研究概览
简要总结
This study aims to assess the clinical significance of the intracytoplasmic sperm injection (ICSI) with zona-pellucida (ZP) bound sperm compared to ICSI with embryologist selected sperm for patients undergoing in vitro fertilization treatment of their infertility.
详细描述
In this study, the investigators aim to determine the clinical utility of the ZP-bound sperm selection methodology for ICSI. This study will be a prospective, split cohort, randomized, control trial comparing the routine standard of sperm selection for ICSI via the embryologist versus sperm selected via ZP-binding for ICSI. Embryology, ploidy and clinical pregnancy outcomes will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 41 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing their first in vitro fertilization (IVF) cycle
- •Electing single embryo transfer
- •Electing preimplantation genetic testing for aneuploidy (PGT-A) of their embryos
- •Female partners age <42 years old at start of vaginal oocyte retrieval cycle, but >18 years old.
- •Normal ovarian reserve:
- •Antimullerian hormone level (AMH) ≥ 1.2 ng/mL
- •Antral follicle count (AFC) ≥ 8
- •At least 4 mature oocytes (M2s) retrieved at the VOR procedure in order to randomize
- •At least 1 immature oocyteretrieved at the VOR procedure to perform ZP binding co-incubation procedure
- •Intention to transfer the morphological best quality, euploid, embryo at the frozen embryo transfer procedure
排除标准
- •Contraindication to IVF
- •Clinical indication for preimplantation genetic testing (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring a more detailed embryo genetic analysis)
- •Male partner with azoospermia or oligozoospermia (<100,000 total motile spermatozoa)
- •Male partner with Y-chromosome microdeletion
- •Male partner with any Karyotype other than 46,XY
- •Male partner requiring surgically obtained sperm either via testicular or epididymal retrieval procedures
- •Uncorrected hydrosalpinges that communicate with the endometrial cavity
- •Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness <6mm,), or persistent endometrial fluid
- •Donor oocyte cycles
- •Gestational carriers
结局指标
主要结局
Blastulation Rate
时间窗: one week after the vaginal oocyte retrieval and ICSI procedure
Blastulation rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI.
次要结局
- Fertilization Rate(24 hours post ICSI procedure)
- Blastocyst Ploidy Rate(Approximately 2 weeks after trophectoderm biopsy)
- Sustained Implantation Rates(Approximately 6 weeks after frozen embryo transfer procedure)